Name: Predicase
Price: 199 USD

K-number	K897072
Device name	NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
Applicant	Kallestad Diag, A Div. of Erbamont, Inc.
Product code	KLI
Device class	Class II
Decision date	Mar 29, 1990
Decision	Substantially Equivalent
Regulation	862.1700

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Source

View the full FDA submission: accessdata.fda.gov

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NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR

Everything you need for a 510(k) submission. Nothing you don't.